Quality Systems Engineer: QMS & Compliance

Johnson & Johnson MedTech; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year

Holiday pay with floating holidays

Job summary

Johnson & Johnson MedTech is seeking a Quality System Engineer to develop and maintain quality management systems ensuring regulatory compliance. You will collaborate with cross-functional teams to drive continuous improvement and embed quality across engineering, manufacturing, and regulatory activities.

The role emphasizes auditing, CAPA, and training staff to strengthen the quality culture, with exposure to ISO and FDA standards in a regulated environment.

Qualifications

• Bachelor's degree in engineering, Quality Management, or a related field.
• At least three years of experience working with quality systems in a regulated industry.
• Comprehensive understanding of ISO, FDA, or other applicable standards.
• Strong analytical, problem-solving, and communication skills.
• Certification in quality management, such as Six Sigma or CQE, is preferred.

Responsibilities

• Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
• Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
• Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
• Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
• Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.
• Manage and track CAPA and non-conformances, ensuring timely resolution and documentation per regulatory requirements.

Skills

Analytical thinking

Problem solving

Communication

Data quality

Quality auditing

Documentation

Training

Education

Bachelor's degree in engineering

Job description

Johnson & Johnson MedTech is seeking a Quality System Engineer to develop and maintain quality management systems ensuring regulatory compliance. You will collaborate with cross-functional teams to drive continuous improvement and embed quality across engineering, manufacturing, and regulatory activities.

The role emphasizes auditing, CAPA, and training staff to strengthen the quality culture, with exposure to ISO and FDA standards in a regulated environment.